Recalls / —

—#97200

Product

MOSAIQ Oncology Information System Intended Use : Electronic Patient Records Management

FDA product code

IYE — Accelerator, Linear, Medical

Device class

Class 2

Medical specialty

Radiology

Affected lot / code info

Part # 10568605

Why it was recalled

The potential for injury to a patient should the treatment data be incorrectly uploaded to patient records.

Root cause (FDA determination)

Software design (manufacturing process)

Action the firm took

Sent an Urgent Medical Device Correction Safety Advisory Notice to customers on 1/11/11. Letters will be delivered by Siemens Customer Service Group or sent by certified mail. Letter identified the affected product and stated there is a potential risk due to a problem identified by the manufacturer. Customers are asked to refer to the attached Safety Notice from Elekta IMPAC Software. A Siemens Service Engineer will contact customers site to arrange for a patient matching criteria audit to determine if you have a problem. Customers should include the Safety Advisory Notice including the Safety Notice from Elekta IMPAC Software in their product related documentation until further notice. If customers have any questions, they should contact their responsible SIEMENS Service Engineer or Application Specialist.

Recalling firm

Firm

Siemens Medical Solutions USA, Inc

Address

4040 Nelson Ave, Concord, California 94520-1200

Distribution

Distribution pattern

International Only Distribution -- Germany and Japan

Timeline

Recall initiated

2011-01-11

Posted by FDA

2011-03-07

Terminated

2012-04-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #97200. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.